Health ministry looks to reduce drug development, approval timelines

The Union Health Ministry has proposed amendments to NDCT Rules 2019 to reduce test licence timelines from 90 to 45 days and ease approvals for BA/BE studies

The Union health ministry is planning to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019 to reduce delays in drug development and approval timelines in the country, with the overall statutory processing time for test licence applications expected to be reduced from 90 to 45 days.

 

In a notification dated September 3, the ministry has sought public comments on the proposed amendments that aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to bioavailability/bioequivalence (BA/BE) studies.

 

“It forms a part of the broader efforts toward ease of doing business to promote the growth of the Indian pharma industry and align domestic regulations with global best practices. These steps are expected to increase the attractiveness of India for clinical research, thereby strengthening India’s position as a global hub for pharmaceutical research and development,” a health ministry statement said.

 

 

India has around 8 per cent share in global clinical trials, and several pharma companies take their early stage trials overseas due to regulatory bottlenecks here. 

 

The amendments would allow companies to conduct certain clinical trials and manufacture the drugs needed for these trials without seeking a license — the activities could begin after simply notifying the regulator. Moreover, the amendments are also intended to ensure quicker initiation of BA/BE studies. These studies are required to demonstrate that any new drug is absorbed in the same manner and induces similar results compared to a previously approved drug.

 

The relaxation, however, will apply only in case of oral formulations that have already been approved in countries with stringent regulatory systems like the EU, UK, Japan, Australia, US and Canada.

 

One of the key amendments proposed includes converting the present system for issuing test licences into a notification/intimation system. Applicants can avoid the wait to obtain licences from the drug regulator and can proceed with their plans after notifying the Central Licensing Authority. A small category of high-risk category drugs will still need to obtain this approval. However, the overall statutory processing time for test licence applications can be reduced from 90 to 45 days according to the amendment.

 

The ministry feels that the proposed amendments will also enable the Central Drugs Standard Control Organisation (CDSCO) to optimise the deployment of its human resources as the number of licence applications submitted can potentially reduce by 50 per cent or so. Quicker beginning of BA/BE studies, testing etc will reduce delays in the drug development and approval processes.

 

The drug regulator has been making consistent efforts to streamline the approval process. Last year, the CDSCO allowed entry of novel drugs into India without the need for local clinical trials, provided these have been approved by a stringent regulator.